phase ⅱ study of pegylated liposomal doxorubicin（pld）plus trastuzumab in her-2 positive metastatic breast cancer

Conditions: HER2-positive Breast Cancer

Summary: this is a single-center phase ⅱ study designed to evaluated the efficacy and safety of pegylated liposomal doxorubicin（pld）in combination with trastuzumab in her-2 positive metastatic breast cancer .


Eligibility criteria:
inclusion criteria: * ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document; * female patients aged from 18 to 70 years old； * histologically confirmed as invasive breast cancer； * her-2 positive（defined by: ihc 3+ or ish positive）, regardless of hr status; * recurrence after adjuvant therapy or metastatic breast cancer，and chemotherapy naïve in the metastatic setting or had one prior regimen for metastatic breast cancer； * patients must have measurable disease according to recist criteria version 1.1（brain metastases lesions and bone metastases lesions were excluded）; * the adverse event caused by prior therapy has recovered, or stabilized, or does not affect the study administration according to the investigator's judgment； * performance status 0-1； * life expectancy of at least 3 months； * left ventricular ejection fraction (lvef)≥55%； * brain natriuretic peptide (bnp) and cardiac troponin t (ctnt) were in the normal range； * patients must have normal ecg； * bone marrow function: absolute neutrophil count (anc)≥1.5×109/l，platelets≥100×109/l，hemoglobin ≥90g/l； * hepatic function：alanine aminotransferase(alt) and aspartate aminotransferase(ast) ≤2.5×uln，serum total bilirubin≤ 1.5×uln，or ≤2.5×uln who has gilbert's syndrome; * renal function：serum creatinine≤1.5×uln； * coagulation function：the international standardized ratio (inr) ≤1.5×uln, prothrombin time (pt) or the activated partial thrombin time (aptt) ≤1.5×uln. exclusion criteria: * patients with symptomatic brain metastases. * patients who are known or suspected to be allergic to the active ingredient or excipients of the investigational drug. * prior cumulative dose of 240 mg/m2 for doxorubicin and 400 mg/m2 for epirubicin. * prior treatment with anthracyclines has caused cardiotoxicity, or failed (disease progression during therapy or recurrence and metastasis within 12 months after adjuvant therapy). * prior mediastinal radiotherapy. * participation in other clinical trials within 4 weeks before enrollment. * severe cardiovascular disease, including history of congestive heart failure, acute myocardial infarction within 6 months before enrollment, transmural myocardial infarction measured by ecg, uncontrolled arrhythmia, angina requiring therapy, clinically significant valvular heart disease, uncontrolled hypertension. * severe or uncontrolled infection. * positivity for hiv, hepatitis b or c. * active malignancy in the past 5 years (other than carcinoma in situ of the cervix or basal cell carcinoma of the skin). * patients who are pregnant , breastfeeding ,or refuse to use adequate contraception during the course of participation. * need to concurrent other cancer therapy(other than palliative care for non-target lesions). * other ineligible conditions according to the researcher's judgment.